Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung

Lung Neoplasms Clinical Trial

— BREATH  

Official title:

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793246
• Other study ID #: MKT_2012_lung_01
• Status: Completed
• Phase: N/A
• First received: February 14, 2013
• Last updated: August 28, 2017
• Start date: February 2013
• Est. completion date: December 24, 2016

Study information

• Verified date: August 2017
• Source: Mauna Kea Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. The hypothesis is that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.

Description:

The primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. Once these criteria have been defined, the diagnostic parameters and the reproducibility of pCLE will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 24, 2016
• Est. primary completion date: December 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female > 18 years of age

• Willing and able to comply with study procedures and provide written informed consent to participate in the study

• Indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic bronchoscopy

• Newly discovered &/or prior discovered non classified nodules, hard to define based on CT scan

• Purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary nodule or multiple lesions

• All lesion locations are acceptable

• Any patient undergoing clinically indicated bronchoscopies after lung transplantation

• Patients post transplant showing clinical signs of acute rejection >3 weeks; < 1 year

• Patient with single or double lung transplant

Exclusion Criteria:

• Contraindication to short-acting anesthetic agents;

• Contraindications to transbronchial biopsy

• Bleeding diathesis;

• A pacemaker/defibrillator;

• A diagnosis by other means (sputum cytology, microbiology).

• Unwilling To Consent

• Unable To Safely Tolerate A Bronchoscopic Procedure

• Unwilling To Comply With Surveillance Bronchoscopy Follow Up

• Chronic Rejection

• Fungal Disease

• Ax Histological Assessment Or Incomplete Biopsy Procedure Should Be Considered As A Screen Failure

Related Conditions & MeSH terms

• Disorder Related to Lung Transplantation
• Lung Neoplasms

Intervention

Device:
• probe based laser endomicroscopy (pCLE)
pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Walter Reed Military Medical Center	Bethesda	Maryland
United States	University of Chicago	Chicago	Illinois
United States	Columbus Regional Hospital	Columbus	Indiana
United States	Ohio State University	Columbus	Ohio
United States	Mayo Clinic	Jacksonville	Florida
United States	St. Joseph's Medical Center	Phoenix	Arizona
United States	University of Rochester	Rochester	New York
United States	University of Louisiana Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Mauna Kea Technologies

Country where clinical trial is conducted

United States, 

References & Publications (19)

DeVito Dabbs A, Hoffman LA, Iacono AT, Wells CL, Grgurich W, Zullo TG, McCurry KR, Dauber JH. Pattern and predictors of early rejection after lung transplantation. Am J Crit Care. 2003 Nov;12(6):497-507. — View Citation

Filner JJ, Bonura EJ, Lau ST, Abounasr KK, Naidich D, Morice RC, Eapen GA, Jimenez CA, Casal RF, Ost D. Bronchoscopic fibered confocal fluorescence microscopy image characteristics and pathologic correlations. J Bronchology Interv Pulmonol. 2011 Jan;18(1):23-30. doi: 10.1097/LBR.0b013e318203da1c. — View Citation

Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. Epub 2006 Jul 27. — View Citation

Gotway MB, Dawn SK, Sellami D, Golden JA, Reddy GP, Keith FM, Webb WR. Acute rejection following lung transplantation: limitations in accuracy of thin-section CT for diagnosis. Radiology. 2001 Oct;221(1):207-12. — View Citation

Henschke CI, Naidich DP, Yankelevitz DF, McGuinness G, McCauley DI, Smith JP, Libby D, Pasmantier M, Vazquez M, Koizumi J, Flieder D, Altorki N, Miettinen OS. Early lung cancer action project: initial findings on repeat screenings. Cancer. 2001 Jul 1;92(1):153-9. — View Citation

Ikeda N, Hayashi A, Iwasaki K, Honda H, Tsuboi M, Usuda J, Kato H. Comprehensive diagnostic bronchoscopy of central type early stage lung cancer. Lung Cancer. 2007 Jun;56(3):295-302. Epub 2007 Feb 8. Review. — View Citation

MacMahon H, Austin JH, Gamsu G, Herold CJ, Jett JR, Naidich DP, Patz EF Jr, Swensen SJ; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology. 2005 Nov;237(2):395-400. — View Citation

Meining A, Chen YK, Pleskow D, Stevens P, Shah RJ, Chuttani R, Michalek J, Slivka A. Direct visualization of indeterminate pancreaticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience. Gastrointest Endosc. 2011 Nov;74(5):961-8. doi: 10.1016/j.gie.2011.05.009. Epub 2011 Jul 29. — View Citation

National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. — View Citation

Newton RC, Kemp SV, Yang GZ, Elson DS, Darzi A, Shah PL. Imaging parenchymal lung diseases with confocal endomicroscopy. Respir Med. 2012 Jan;106(1):127-37. doi: 10.1016/j.rmed.2011.09.009. Epub 2011 Oct 14. — View Citation

Ohtani K, Lee AM, Lam S. Frontiers in bronchoscopic imaging. Respirology. 2012 Feb;17(2):261-9. doi: 10.1111/j.1440-1843.2011.02108.x. Review. — View Citation

Pohl H, Rösch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28. — View Citation

Salaün M, Bourg-Heckly G, Thiberville L. [Confocal endomicroscopy of the lung: from the bronchus to the alveolus]. Rev Mal Respir. 2010 Jun;27(6):579-88. doi: 10.1016/j.rmr.2009.12.009. Epub 2010 Jun 2. French. — View Citation

Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13. — View Citation

Thiberville L, Salaün M, Lachkar S, Dominique S, Moreno-Swirc S, Vever-Bizet C, Bourg-Heckly G. Human in vivo fluorescence microimaging of the alveolar ducts and sacs during bronchoscopy. Eur Respir J. 2009 May;33(5):974-85. doi: 10.1183/09031936.00083708. Epub 2009 Feb 12. — View Citation

Thiberville L, Salaün M. Bronchoscopic advances: on the way to the cells. Respiration. 2010;79(6):441-9. doi: 10.1159/000313495. Epub 2010 May 12. Review. — View Citation

Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764. — View Citation

Wilson DS, Bartlett RJ. Improved Diagnostic Yield of Bronchoscopy in a Community Practice: Combination of Electromagnetic Navigation System and Rapid On-site Evaluation. Journal of Bronchology & Interventional Pulmonology 2007;14:227-232 10.1097/LBR.0b013e31815a7b00.

Yick CY, von der Thüsen JH, Bel EH, Sterk PJ, Kunst PW. In vivo imaging of the airway wall in asthma: fibered confocal fluorescence microscopy in relation to histology and lung function. Respir Res. 2011 Jun 23;12(1):85. doi: 10.1186/1465-9921-12-85. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.	For Group 1 - Discrete lung lesions	Up to 12 months
Primary	Diagnostic performance of the pCLE image interpretation criteria for discrete lung lesions and for acute lung rejection in lung transplant.	For Group 2 - Transplant rejection	Up to 12 months.